NCT00282633

Brief Summary

A Comparison of Skin Closure Techniques after Primary Cesarean Delivery. Traci N. Gray, M.D. and Peter F. Schnatz, D.O. A prospective, observer blinded, randomized, and controlled trial comparing Dermabond closure technique to suture closure of skin. Study Participants: All women age 18years or older who provide informed consent prior to primary Cesarean delivery at Hartford Hospital. Women with vertical skin incisions and or who are febrile preop or intraop will be excluded. Methods: Qualified participants will then be randomized to skin closure with either Dermabond or suture. Surgeon preference will dictate usage of 4-0 monocryl or 4-0 vicryl for skin closure for patients randomized to the suture arm.

  • The circulating nurse will time all skin closures.
  • The surgeon will complete a 3 question survey immediately postop.
  • At the 6 week post partum visit, patients and the health care professional will complete a brief query regarding cosmetic appeal and pain. A disposable camera will be supplied to each provider office and a photo will be taken of the incision.
  • All photos will be evaluated for cosmesis by physicians who will be blinded to the methods of skin closure. Primary Outcomes: To compare the time needed to close skin. To compare cosmetic outcome after healing Secondary Outcomes: Patient Pain scores. Provider and patient satisfaction. Responses to questions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 31, 2007

Status Verified

October 1, 2007

First QC Date

January 25, 2006

Last Update Submit

October 30, 2007

Conditions

Wounds, Closure

Keywords

Cesarean DeliveryWound closureSutureAlternative therapySurgery

Outcome Measures

Primary Outcomes (2)

  • Time needed to close skin.

  • Cosmetic outcome after healing

Secondary Outcomes (3)

  • Patient Pain scores.

  • Provider and patient satisfaction.

  • Responses to questions.

Interventions

DermabondDEVICE

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing a primary Cesarean Delivery
  • Eighteen years of age or older

You may not qualify if:

  • Allergy to Dermabond
  • Fever pre or intra operatively
  • The need for a vertical skin incision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Peter F. Schnatz, D.O.

    Hartford Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2006

First Posted

January 27, 2006

Study Start

November 1, 2005

Study Completion

December 1, 2008

Last Updated

October 31, 2007

Record last verified: 2007-10

Locations

US(1)